199 – How Modeling Can Cut in Half for Combination Products, V&V 40, and Cutting Dev Time with Mark Burchnall

In this episode of Let’s Combinate, host Subhi Saadeh is joined by Mark Burchnall, Director of Engineering at PSN Labs, to break down the evolving role of mechanical modeling and simulation in medical device and combination product development.

Mark, an expert in mechanical modeling & finite element analysis (FEA) and a licensed professional engineershares how modeling can dramatically reduce prototyping cycles, support regulatory submissions, and lower test burden when applied appropriately.

Mark disucsses:

Why modeling is often misunderstood

When it can replace (or complement) traditional testing

What makes a model “credible” under ASME V&V 40

How to build internal processes for regulatory-grade models

And what every skeptic (or startup) needs to know before adopting modeling

Timestamps

00:00 Introduction and Guest Welcome
00:17 Mark's Expertise in Mechanical Modeling
01:28 Subhi’s Foundational Experience
04:09 The Importance of Modeling in Engineering
05:44 Challenges and Misconceptions in Modeling
10:52 Life Cycle and Inputs of a Model
16:21 Types of Models and Their Applications
17:49 Numerical Solvers and Sensitivity Analysis
21:28 CAD, Fluid Properties, and Starting a Model
22:00 Defining the “Question of Interest”
23:21 Modeling Cycle and Initial Steps
24:35 Verification and Validation in Modeling
25:40 Assessing Model Risk and Credibility
31:43 Regulatory Guidelines and Industry Practices
39:15 Implementing Modeling in Product Development
42:17 Conclusion and Contact Information

Mark is a product development consultant with over 15 years of experience in the Medical and Combination device sectors. As the Director of Engineering at PSN Labs, Mark leads the engineering department, offering invaluable support to clients in new product development, computational modeling and simulation, test method development, functional prototyping, contract manufacturing, and on-market remediation. His team specializes in designing devices that incorporate various design principles, including manufacturing, assembly, sustainability, biocompatibility, reprocessing, and reliability. Mark’s background encompasses the development of innovative healthcare solutions in areas such as drug delivery, surgical robotics, pharmaceutical packaging, and catheters. His expertise ensures patient safety and regulatory compliance throughout the design process. Mark holds a Bachelor of Science in Mechanical Engineering from Purdue University and a Master of Science in Mechanical Engineering from the University of Cincinnati.

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.